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From: tom pope	12/18/2006 1:35:16 PM
	of 2173

Merrill: Lowering Byetta estimates on NDC data Amylin and Lilly expect Byetta sales to reaccelerate as they reduce sampling, but based on flat NDC data thus far, we are lowering our 4Q06 Byetta sales estimate to $145mn from $158mn. Maintain Neutral. Flat Byetta weekly sales in 4Q06 Based on NDC data, weekly Byetta sales are averaging $11.4mn in 4Q06, above the $10.3mn in 3Q06, and we still assume weekly sales increases of about 3% over the final three weeks. But sales in 4Q06 have been flat so far and Byetta’s annual run rate has also leveled to about $600mn. Lowering EPS est. modestly on lower Byetta estimates Our reduced 4Q06 Byetta sales estimate of $145mn lowers our full year Byetta sales estimates to $439mn from $451mn in 2006 and to $772mn from $810mn in 2007. Accordingly, we widened our EPS loss estimates modestly to $1.89 from $1.85 in 4Q06 and to $1.61 from $1.48 in 2007. Maintain Neutral AMLN stock appears modestly attractive below $40 on a long-term basis, based on our NPV model, assuming Byetta can begin to perk up. But we believe it is facing competitive pressures from Januvia’s strong launch and we maintain our Neutral rating.

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To: tom pope who wrote (2045)	12/22/2006 4:18:59 PM
From: tuck	of 2173

>>FDA Approves BYETTA(R) (exenatide) Injection for Expanded Combination Use Friday December 22, 4:05 pm ET Millions of People Using Thiazolidinediones Now Have New Treatment Option to Manage Type 2 Diabetes SAN DIEGO and INDIANAPOLIS, Dec. 22 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN - News) and Eli Lilly and Company (NYSE: LLY - News) announced today that the U.S. Food and Drug Administration (FDA) has approved BYETTA® (exenatide) injection as an add-on therapy to improve blood sugar control in people with type 2 diabetes who have not achieved adequate control on a thiazolidinedione (TZD). Healthcare professionals will be educated on this additional use for BYETTA in the coming weeks. In a clinical trial designed to evaluate BYETTA for use in combination with a TZD, 62 percent of patients who added BYETTA to their existing medicines achieved an A1C (a measure of blood glucose levels over time) of 7 percent or less, compared to 16 percent of the patients on placebo. People taking BYETTA also lost an average of 3.3 pounds over 16 weeks, compared to an average weight reduction of 0.4 pounds in the other group. The most common adverse event associated with BYETTA was nausea (40 percent)(1)(2). "Due to the progressive nature of type 2 diabetes, previous approaches to management frequently failed to achieve target levels of A1C, or resulted in subsequent failure over one to three years," said Dr. Robert Ratner, Vice President for Scientific Affairs at the MedStar Research Institute in Washington, DC. "The combination of exenatide with metformin, sulfonylureas, or TZDs not only expands our options to achieve optimal glycemic control, but does so with accompanying weight loss." BYETTA improves blood sugar control by lowering both post-meal and fasting (early morning) glucose levels resulting in better long-term control as measured by A1C. BYETTA controls blood sugar through several physiologic actions, including the stimulation of insulin secretion only when blood sugar is high. BYETTA restores the first-phase insulin response (an activity of the cells in the pancreas that is lost in patients who have type 2 diabetes), decreases glucose output from the liver, regulates gastric emptying, and decreases food intake. The majority of patients in long-term BYETTA clinical studies also experienced weight loss. "Almost half a million people with type 2 diabetes have used BYETTA to help reduce their blood sugar," said Ginger L. Graham, Chief Executive Officer, Amylin Pharmaceuticals. "Now, even more people -- those who use another common category of oral medicines, TZDs -- have a new treatment option and have the opportunity to benefit from the unique clinical benefits of BYETTA." "There are two core defects to type 2 diabetes, beta cell failure and insulin resistance," said Vince Mihalik, Global Brand Development Leader for Diabetes and Endocrine, Lilly. "The ability of BYETTA to improve beta cell responsiveness and lower weight complements the TZD effect on insulin resistance very nicely."<< snip This may jumpstart sales a bit? Not sure how widely anticipated this was. Disclosure: recently went long. Cheers, Tuck

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To: tuck who wrote (2046)	12/22/2006 8:25:17 PM
From: tom pope	of 2173

The market may welcome the news, but ML is not terribly impressed: Byetta label expanded to include combo use with TZD’s The FDA has approved an expanded label for Byetta to include its use in combination with thiazolidinediones (TZDs), e.g. Actos, Avandia, in people with type 2 diabetes who have not achieved adequate glucose control on a TZD. Byetta is already being used in this capacity and our model has long assumed approval of the expanded label. We are leaving our estimates intact and maintain our Neutral rating. Approval of expanded label to include TZDs assumed Byetta is currently approved as an add-on treatment for type 2 diabetes in patients failing metformin and/or sulfonylureas, but it also is being used in patients failing TZDs. A supplemental NDA was filed in 1Q06 and we had assumed approval of the expanded label. In a clinical trial, 62% of patients on the combination of Byetta and a TZD achieved an A1C of 7% or less vs. 16% of patients on placebo. Patients on the combination also lost an average of 3.3 lb over 16 weeks vs. 0.4 lb for placebo. No changes to Byetta estimates We recently reduced our 4Q06 Byetta estimate to $145mn from $158mn and our full year 2006 estimate to $439mn from $452mn, as weekly NDC data have been flat for the quarter. We are leaving our estimates unchanged on the label expansion as our model has assumed combination use with TZD. Maintain Neutral Although NDC data for the average weekly sales of Byetta are sequentially up about 10% over 3Q06, sales have been flat in 4Q06. AMLN stock appears modestly attractive below $40 on a long-term basis, based on our NPV model, assuming Byetta can begin to perk up. But we believe it is facing competitive pressures from Januvia’s strong launch and we maintain our Neutral rating

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From: tom pope	1/31/2007 9:35:48 AM
	of 2173

Merrill: 4Q06 loss narrows but looking for Byetta traction Amylin reported 4Q06 EPS loss of ($0.45), narrower that our ($0.57) est. and consensus of ($0.52), as modestly light Byetta sales were more than offset by higher collaborative revenues, higher gross margin (93%) and lower operating expenses. But we await signs of traction for Byetta as the company engages in heavy sampling and marketing efforts. Maintain Neutral. Byetta $137mn vs $140mn est., Symlin in-line at $14mn Byetta sales totaled $137mn in 4Q06, modestly missing our $140mn est., as new scripts (NRx’s) were impacted by free sampling of the 5mcg pens. Amylin believes sales growth will lag the heavy sampling by several months, but for now the run rate has leveled at $600mn. Inventory was a non-issue in the quarter. Modestly lowering Byetta estimates, but easing EPS losses We modestly lowered our Byetta U.S. sales estimates to $697mn from $710mn in 2007 and to $887mn from $902mn in 2008. But we narrowed our EPS loss estimates to ($1.47) from ($1.77) in 2007 and to ($1.25) from ($1.27) in 2008 mainly on higher expected gross margins and collaborative revenues. On the pipeline front, Amylin continues to expect data on Exenatide LAR and data from pramlintide combination studies in obesity in 2H07. Maintain Neutral We maintain our Neutral rating, as we do not expect profitability for the foreseeable future due to heavy marketing spending for Byetta in an increasingly competitive environment. Our hypothetical NPV valuation is about $40, which assumes a high probability of launch and commercial success for exenatide LAR.

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From: tom pope	2/7/2007 8:43:54 AM
	of 2173

Merrill, neutral. ML Conference Highlights Reiterated anticipated timelines in diabetes and obesity Dan Bradbury, President and COO, represented Amylin at the Merrill Lynch Global Pharma, Biotech & Medtech conference. He discussed the Byetta script trends, expecting to see positive results in the next few months from the heavy sampling activity and he reiterated the various timelines for the diabetes and obesity programs. Byetta and Symlin expansions, exenatide LAR data Amylin expects to hear from the FDA on its room temperature storage instructions for Byetta in 1H07. The company anticipates that Lilly will launch Byetta in Europe in 2Q-3Q07. Data is expected from the Byetta monotherapy trial in 2H07. The 300-patient trial for exenatide LAR is expected to complete enrollment in 1Q07, with data in 2H07. The Symlin injector pen should be available in 2H07 and Amylin expects label expansion for adding Symlin at mealtime to a once-a-day basal insulin regimen in 2H07. 2007 important for obesity program Amylin expects data from a phase II trial of pramlintide in combination with the oral obesity drugs sibutramine (Meridia) and phentermine in 2H07. It has initiated a phase I multi-dose safety and tolerability trial for pramlintide in combination with PYY-336. Data is expected in 2H07 from a phase II proof-of-concept study for pramlintide in combination with leptin and the company is planning a proof-ofconcept study of the combination of pramlintide in combination with PYY-336 and leptin in 2007. Amylin might consider a combination trial with Acomplia, if approved.

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From: idos	6/5/2007 5:48:42 AM
	of 2173

Zacks downgraded from hold to sell: June 4th, 2007 >Amylin Pharmaceuticals, Inc. is engaged in the discovery, development and commercialization of potential drug candidates for the treatment of diabetes, obesity and cardiovascular diseases. The top-line is being driven by sales of two diabetes drugs, Byetta and Symlin. Sales of both drugs were lower than expected in the most recent quarter due to heavy sampling and increased competition. We think the competitive landscape is only getting worse for Amylin, and despite the fact that we are enthusiastic about the early-to-mid stage pipeline, we feel the name is overvalued. Amylin trades at 33x our 2010 EPS estimate of $1.36. This is a significant premium to the peer group. We would avoid the name. Our target is $36.<

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From: Doc Bones	6/27/2007 4:26:02 AM
	of 2173

Diabetes Drug Has Good Results In Long Trial By JENNIFER CORBETT DOOREN June 26, 2007; [WSJ] Page D2 CHICAGO -- Many patients treated with Byetta, a diabetes drug by Amylin Pharmaceuticals Inc. and Eli Lilly & Co., were able to maintain good blood-sugar control and also lose weight after three years on the drug, according to a study. The study, described at the American Diabetes Association's annual meeting here, examines clinical data from the longest trial involving Byetta presented to date. Byetta, an injection taken prior to morning and evening meals, was approved by the Food and Drug Administration in 2005 for use in people with Type 2 diabetes who weren't able to have their blood-sugar or blood glucose levels effectively lowered with other diabetes medications. People with Type 2 diabetes either don't produce enough insulin or cannot properly use it. Insulin, produced by the pancreas, is needed to take sugar from blood into cells. Byetta is a synthetic form of hormone taken from a lizard that's similar to a human hormone in the digestive track known as GLP-1. The hormone works to boost the production of insulin in order to regulate blood-sugar levels. The study, presented by John Buse, the chief of endocrinology at the University of North Carolina School of Medicine in Chapel Hill, involved 217 patients who weren't getting adequate blood-sugar control with other diabetes drugs metformin or sulfonylurea. Sulfonylurea is designed to stimulate the pancreas to release insulin and metformin works on the liver. Byetta was added to the other drugs. After three years, 46% of patients were able to maintain blood-glucose, or blood-sugar, levels of 7%, and 30% of patients had levels of 6.5%. A level below 7% is considered good blood sugar or blood-glucose control for people with diabetes. Patients also lost an average of 11 pounds over the three-year period. Dr. Buse said that "the weight loss factor is important because being overweight and weight gain is an almost universal problem for people with diabetes." Byetta also slows the emptying of the stomach and causes a decrease in appetite, leading to weight loss. Dr. Buse also said another part of the study that looked at pancreatic beta-cell function in 92 patients showed it improved by 17% over three years, suggesting Byetta might improve the body's own insulin production. online.wsj.com

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